Genetically Modified Organisms - Swansea University

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SWANSEA UNIVERSITY



Document Ref: SWG/021

Issue 001


Revised July 2008


1

Safe Working Guidelines (SWG)

Local Rules for Genetic Modification Work


1.
The genetic modification work permitted in the
University

under the Genetically
Modified Organisms (Contained Use) Regulations 2000
and subsequent
amendments

http://www.hse.gov.uk/biosafety/gmo/law.htm


is set out in the relevant risk assessments approved by the
University Bio Hazards
Working Group and kept by
Prof.

David

Skibinski (DOFS), the Genetic Modific
ation
Biologic
al Safety Officer
. Genetic modification in relation to an organism means the
altering of the genetic material in that organism in a way that does not occur naturally
by mating or by natural recombination or by both. Contained use means an activity
in whi
ch organisms are genetically modified or in which genetically modified
organisms are cultured, stored, transported, destroyed, disposed of or used in any
other way. Detailed guidance on those activities defined as genetic modification in
relation to the re
gulations is given in the HSE
Compendium of G
uidance for GM
activities.

http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/

Additional
useful information on
the Regulations

and their implem
entation

can be
obtained from

this

web

site
.


http://www.hse.gov.uk/biosafety/gmo/index.htm


2.
All personnel must seek permission from the
Bio Hazards Working Group
before
beginning work and m
ust comprehend the definition of genetic modification as
given

in the Genetically Modified Organisms (Contained Use) Regulations 2000.
Personnel must comprehend the requirements of the different containment levels
used for genetic modification work. Plann
ed work requiring containment at level 2 (or
above) should be discussed with the Genetic Modification Biological Safety Officer
(DOFS) before the risk assessment is submitted to the
Bio Hazards Working Group
for
consideration
.

Individual activities at cont
ainment level 2

(or above)

must be
notified

to HSE,

and HSE
will make

a site visit prior to giving consent.
At present all
approved work on campus is at containment level 1.


3.
Only personnel
associated with an approved risk assessment are permitted to
c
arry out genetic modification work
.
For each project
for which a risk assessment
has been made,
the list of personnel working on the project should be appended to
the risk assessment and updated regularly.


4.
Personnel wishing to carry out genetic modifi
cation work must study the
Genetically Modified Organisms (Contained Use) Regulations 2000 and associated
guidance notes.


5.
Before beginning genetic modification work an individual must discuss the safety
aspects of the work with colleagues, supervisors,

and representatives of the
Bio
Hazards Working Group

and carry out and set down in writing a risk assessment for
the proposed work. The risks to both human health and the environment should be
considered in the assessment. Information on completing a ri
sk assessment is
available from DOFS and further information, which should be studied, is
given on
the HSE web site. Of particular value
is

this document with
suggest
ions on an
appropriate
format for the risk assessment
,

SWANSEA UNIVERSITY



Document Ref: SWG/021

Issue 001


Revised July 2008


2

http://www.hse.gov.uk/biosafety/gmo/acgm/acgm31/paper6.pdf

Examples of risk assessments following this format are available from DOFS.


6.
Before beginning genetic modification work an individual must be trained
app
ropriately for carrying out the work, and thus must discuss a training programme
with colleagues and supervisors.


7.
An individual wishing to carry out genetic modification work must arrange with
DOFS for an inspection of the facilities where the genetic
modification work is to be
carried out. Work cannot proceed until this inspection has been made and the
facilities approved.


8.
Established protocols must be used in genetic modification work.


9.
The Local Rules for Genetic Modification Work (ie this doc
ument) should be
displayed in all laboratories where genetic modification work is being carried out


10.
Laboratory personnel must have received instruction in the procedures to be
conducted in the laboratory during genetic modification work.


11.
Contai
nment measures.


The following containment measures apply to work car
ried out at containment level
1:



Bench surfaces should be impervious to water and resistant to acids, alkalis,
solvents, disinfectants and decontaminating agents and be easy to clean.


Suitable protective clothing should be worn.


The disinfectant ‘Virkon’
or equivalent, depending on circumstances,
should be used
for dealing with liquid waste according to the manufacturers instructions.


All waste material containing genetically modified

organisms should be autoclaved
before disposal. Autoclave bags used for the collection of solid waste should not be
overfilled and should be opened at the neck prior to autoclaving to allow attainment
of the correct sterilisation temperature and to allow
free penetration of steam.
Autoclaving must be carried out at 121
o
C for 15 minutes or its equivalent.


Genetically modified organisms should be stored in cupboards, fridges or freezers
that are labelled on the outside to indicate that they contain geneti
cally modified
organisms.


For containment level 2 additional measures are required:

These are described in PART II of Schedule 8
http://www.hmso.gov.uk/si/si2000/20002831.htm

This

also gives t
he measures

for

containment levels
3, and 4.
Information is also
give in the

Compendium of Guidance
(see link above)
.

Some modifications were made to containment measures in the 2005 amendment
http://www.hse.gov.uk/biosafety/gmo/guidance/amendingregs.pdf

)

SWANSEA UNIVERSITY



Document Ref: SWG/021

Issue 001


Revised July 2008


3

12. Autoclaves


The permissible autoclaves for use
for

GM
waste

are,


i)

The “waste” autoclave
ILS

5
th

floor room 514

(serial no. 2467)
. Please note
that this is the only autocl
ave currently approved for the inactivation of
waste produced as a result of Class 2 activities.

ii)

Both autoclaves on the ground floor of ILS (serial nos. 2469 and 2470)

iii)

The Priorclave a
utoclave Margam
room 103 (serial no. 2542)


13
.
The Genetic Modification

Safety Officer (DOFS) must be asked for guidance
when

ancillary and maintenance staff, contractors and visitor are likely to be
present in the laboratory.


14
.
Personnel should report cases of unusual or repeated illness to their
doctor

and
to DOFS.
Personnel must be aware that it is inadvisable to carry out genetic
modification work when receiving some kinds of medication, for example,
immunosuppressant drugs. If in doubt, medical advice must be sought.


15
.
Laboratory personnel must inform DOFS of
any failures or suspected failures in
ventilation systems, air filters, microbiological safety cabinets and other safety
equipment in the laboratory where genetic modification work is carried out.


16
.
The local rules must be used in conjunction with other

local rules and safety
regulations which are in force and have bearing on the genetic modification work
being carried out, for example, those local rules and safety regulations which apply
to personnel working with radioisotopes.


17
.
When

DOFS

is not ava
ilable,

advice

on any matters referred to above should be
sought from the Deputy Genetic Modification Biological Safety Officer
s Prof
.

P. J.
Dyson and Dr
Dr. Geertje van Keulen.


APPENDIX to Local Rules for Genetic Modification Work


Undergraduate Practic
al
Classes


18
.
An academic staff member wishing to carry out an undergraduate or MSc Course
practical class that involves genetic modification work must seek permission for this
from the GM Bio
logical Safety Officer or Deputies
.


19
.
Students carrying out

such practical work must only do so under the direct
supervision of the staff member in charge of the practical class and should adhere as
far as is feasible to the Local Rules for Genetic Modification Work. These rules
should be referred to in the Safet
y assessment for the practical class and should be
displayed in the laboratory during the practical class.


20
.
The special safety requirements and procedures for genetic modification work
should be explained to students in the talk that precedes the pract
ical class.


D.O.F. Skibinski

GM Biological Safety Officer